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Assessment of Diaper-Clogging Potential of Petrolatum Moisture Barriers
Incontinence is both a prevalent1,2 and costly3 condition among older adults that is often managed with disposable and reusable absorbent incontinence products such as pantiliners, protective underwear, and adult briefs.4,5 Individuals residing ininstitutions or long-term care settings tend to have more severe urinary incontinence than community-dwelling individuals, necessitating use of highly absorbent incontinence products.6
Unlike reusable incontinence products, disposable adult briefs are constructed of specialized multiple layers that have a surface area directed against the perineum to collect and transmit urine to a super absorbent polymer inner core.7 This absorbent inner core allows the urine to spread throughout the entire product, facilitating absorption capacity while preventing urine leakage and odor.8 Newer products have a “breathable” plastic film layer with micro-porous openings that allow water vapor to pass to the outside. Anecdotal reports to the authors from users of absorbent briefs indicate that petrolatum-based ointments, often used to treat and prevent incontinence dermatitis, may coat the inner liner of the disposable brief and interfere with passage of moisture to the absorbent inner core. A recent systematic review of the effectiveness of incontinence products found no published studies that included the use or compatibility of skin care products with absorbent incontinence products.5 Therefore, the objective of this study was to examine the potential impact of four incontinence moisture barriers (three ointments and one non-alcohol barrier film) on the efficacy of absorbent briefs in a controlled laboratory setting.
Results of the current study have appeared elsewhere in summary form9 and are frequently are cited in the incontinence literature. Because the previously published summary did not provide details of the study methods used, they are presented herein so researchers and clinicians can evaluate the merit of the data. In addition, skin care product formulations and absorbent brief designs are basically the same today as they were when this study was conducted. Petrolatum-based ointments are commonly used incontinence skin barriers and barrier film usage has increased since the time this study was conducted.1,5 Therefore the methodology, data, and conclusions of this study are as relevant today as they were 12 years ago when the data were collected.
Methodology
Design. The randomized, balanced-block design of this study allowed for cross-comparison of four commercially available skin barrier products commonly used to treat and prevent incontinence dermatitis. The study was conducted at KGL Skin Study Center, Broomall, Pa., from August 20, 1993 to August 26, 1993. Two treatment technicians were under the direct supervision of an author/researcher.
Subjects. Sixteen, healthy adult volunteers were recruited from the vicinity of the testing laboratory. Subjects were between 18 and 45 years of age and determined by interview to be in good general health. On the day of testing, subjects were not permitted to use any topical skin care products on their arms. This included any moisturizers, creams, lotions, or oils. Subjects were allowed to bathe as usual, which typically included a brief soap and water shower before reporting to the test laboratory.
Ethical considerations. This study was conducted in compliance with Good Clinical Practice10 and was conducted before implementation of Health Insurance Portability and Accountability Act regulations (HIPAA).11 Informed consent was obtained from all subjects participating in the study.
Test sites and test products. A treatment technician mapped two 6-cm x 6-cm test sites onto each volar forearm of the participating subjects. The test sites were delineated with a skin marker and given identification as to left/right arm (L or R) and 1 (nearest to wrist) or 2 (nearest to elbow). Test products were applied to each of the test sites using a predetermined randomization schedule. The balanced-block design of the study ensured each test product appeared an equal number of times on each of the four test sites across all subjects.
Test products used in this study were obtained from a national medical supply distributor and included: 3M™Cavilon™ No Sting Barrier Film (3M Company, St. Paul, Minn.) — Product A; Sween Peri-Care® Moisture Barrier Ointment (Coloplast Group, Humlebæk, Denmark — Product B; Fougera® Vitamin A + Vitamin D Ointment (Fougera A&D Schering-Plough HealthCare Products, Inc., Memphis, Tenn.) — Product C; and Vaseline Petroleum Jelly (Tyco Health Care/Kendall, Mansfield, Mass.) — Product D.
The treatment technician applied Product A, supplied as a swab applicator, by wiping the swab across the test site in one direction. After 1 minute, the product was applied a second time in a criss-cross manner and allowed to dry for an additional minute. The swab and associated packaging was weighed before and after application to calculate the amount of test product applied to the skin.
For the three petrolatum ointments (Products B, C, and D), the treatment technician applied approximately 0.3 cc of the appropriate test product with a clean tuberculin syringe to the center of a weighing dish to obtain the initial weight of test product plus the weighing dish and a clean glass application rod. The treatment technician then transferred the test product to the appropriate treatment site with the glass rod and subsequently re-weighed the weighing dish and glass rod to determine the amount of test product actually applied to each treatment site. This amount of ointment (approximately 0.3 cc) was previously determined by the study investigators to be an amount similar to that normally encountered in a clinical environment for a proportionally sized area of skin. The ointment products were allowed to sit on the skin for 1 minute before testing.
Mini briefs. Depend® Fitted Briefs (Kimberly-Clark Corporation, Neenah, Wis.) were used for testing in this study. This product is readily available through multiple distribution channels (eg, retail, mail order, and medical supply outlets) and, therefore, was chosen to represent a typical adult absorbent brief. For testing purposes, this product was converted into mini briefs in a manner that retained structural integrity of the absorbent brief. This entailed stretching out the brief and undermining the elastic gatherers by snipping them with a scissors. The central portion then was subdivided into squares that were approximately 3 inches at the edge (see Figure 1). The cut edges then were sealed back together with 3M™ Scotch® Commercial Grade Box Sealing tape (3M Company, St. Paul, Minn.), leaving a 2.25-cm x 2.25-cm exposed absorbent surface that could be placed on the skin (see Figure 2). Each mini brief was given a unique identifying number and weighed before study use.
Sequence of study events. The test sites were treated and tested one at a time in the order R1, R2, L1, L2. For each test site on each subject, the treated test site was covered with a pre-weighed mini brief. The subject’s arm then was turned over so that the arm was pressing against the mini brief under its own weight. After 5 minutes, the treatment technician pressed firmly against the mini brief and moved it around for 1 minute to simulate movement patterns and weights that might occur in a practice environment. The mini brief was removed and re-weighed to determine the amount of test product transferring from the skin to the mini brief.
The mini briefs then were tested for their fluid absorption efficacy (see Figure 3). A small rubber tube connected to a fluid-filled syringe was placed in the center of the test site. The mini brief was placed back over the test site in the same orientation used for the transfer part of the test. The subject’s arm was once again positioned to rest on the mini brief. The treatment technician then introduced 3.0 mL of a synthetic urine solution between the skin and the mini brief in a steady flow for 15 seconds. The synthetic urine solution consisted of distilled water containing 1% sodium chloride and 0.0025% of the nonionic wetting agent/surfactant octoxynol-9 (CAS 9002-93-1).12 The mini brief then was removed and immediately weighed to determine its wet weight and then allowed to thoroughly dry over 24 hours in a drying oven to determine dry weight and, thus, amount of fluid uptake.
Statistical analysis. Results of test product amount applied to the skin, the amount transferred to the mini brief, and the percent of fluid absorbed by the mini briefs were summarized using descriptive statistics (mean and standard deviation). The percent of test product that transferred to the mini brief was calculated by dividing the weight gain of the mini brief after the 5-minute application period by the amount of test product originally applied to the skin. The percent of fluid absorption was calculated by dividing the difference in the wet and dry weights of the mini brief by the theoretical weight of fluid infused between the skin and the mini brief (assuming a synthetic urine fluid density of 1.0 g/mL). A repeated measure ANOVA was used to compare the amount of product that transferred to the mini brief as well as the net uptake of synthetic urine. Post-hoc multiple comparisons were performed using Tukey’s protected t-test, which allowed for examination of all possible combinations of the four treatment group means, while controlling the level of significance. For all analyses, a two-tailed distribution with P <0.05 was used for the level of significance.
Results
The mean (standard deviation [SD]) test product application weights were 0.51 g (±0.08), 0.34 g (±0.04), 0.33 g (±0.04), and 0.33 g (±0.05) for Products A, B, C, and D, respectively.
The mean amount of product transferred from the skin to the mini brief was 0.0 g (±0.0), 0.19 g (±0.06), 0.21 g (±0.03), and 0.23 g (±0.05) for Products A, B, C, and D, respectively. The calculated mean (SD) percent transfer of product was 0.0% (±0.0%), 59.38% ±16.08%), 62.52% (±9.63%), and 68.76% (±11.96%) for Products A, B, C, and D, respectively; the F-ratio = 138.2934, with 3 degrees of freedom, P <0.0001) (see Figure 4). Tukey’s protected t-tests showed that significantly less barrier film (Product A) transferred to the mini briefs than Products B, C, or D (P <0.01). Among the ointment products, the only significant difference in transfer weight was between Product B and Product D (P <0.05). No other significant differences were found.
Mini brief fluid absorption data. The mean (SD) percent of fluid absorbed by the mini brief was 98.23% (± 2.14%), 46.25% (±33.86%), 16.98% (±27.19%), and 9.79% (±21.25%) for Products A, B, C, and D, respectively (F-ratio = 55.3975, with 3 degrees of freedom, P <0.0001) (see Figure 4). Tukey’s protected t-test showed significantly more fluid was absorbed by the mini briefs on the barrier film-treated sites than any of the other test products (P <0.01). Significant differences also were noted among the ointment products. Mini briefs on sites treated with Products C and D absorbed significantly less fluid than the mini briefs on sites treated with Product B (P <0.01).
Discussion
Results of this study suggest that petrolatum-based ointments, which are routinely used to protect the skin of individuals with incontinence, can transfer from the skin to absorbent products in a controlled laboratory setting. In this study, between 59% and 69% (by weight) of the three ointment products tested transferred to the mini briefs within 5 minutes of application. This resulted in a 54% to 90% reduction in function of the mini briefs, as measured by fluid absorption tests. The four test products exhibited an inverse relationship with regard to the amount of petrolatum contained in the formulation (as listed on the label) and the amount of fluid absorbed by the mini brief applied to the test site. Product D contained the greatest amount of petrolatum (100%) and exhibited the greatest interference with mini brief function (only 9.8% fluid absorption). Product A contained no petrolatum and exhibited the least interference in mini brief function (98.2% fluid absorption). Product C (53% petrolatum) and Product D (unknown amount of petrolatum) produced intermediate interference in mini brief function, with 17.0% and 46.3% mini brief fluid absorption, respectively. These results suggest that petrolatum has the potential to interfere with the fluid handling function of absorbent briefs in a dose- dependent manner.
An inherent limitation of this study is the time frame in which it was performed. Since this study was conducted, the products tested may have changed in design and formulation. The percent of inactive ingredients is not disclosed on product labels, making it impossible to determine whether products are exactly the same. Also, Product B now is available as Baza® Clear Skin Protectant Ointment (Coloplast Corp., Marietta, Ga.).
A second limitation of this study is that only one type of absorbent product was tested, which may or may not be reflective of other brands and designs available in consumer or institutional markets. Although both limitations may affect the results of the products evaluated, the general results and conclusions regarding the potential for interference of incontinence skin care products with absorbent products remain applicable. Finally, due to the controlled laboratory design of this study, caution must be used in projecting these results to an actual clinical environment. In particular, body weights/movements and urinary volumes of patients with incontinence are likely to be highly variable in a practice environment and it is unknown if the standardized methods used to simulate these variables in this study reflect actual conditions.
Conclusion
Results of this study indicate that some incontinence skin care products have the potential to interfere with the efficacy of disposable absorbent products commonly used to manage urinary incontinence. Specifically, the three petrolatum-based products that were tested in this model hampered fluid absorption, while a non-alcohol polymer based film did not. These data indicate that further research is needed to validate this research model in clinical practice and to include a wider variety of skin care and absorptive products currently available.
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